GE Healthcare, LLC: (1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.

Is my product affected?

(1) GE Centricity Universal Viewer 6.0, Model 2088026-9XX; (2) GE Centricity Universal Viewer 7.0, Model 5826659-0XX; (3) GE Universal Viewer 8.0, Model 5865740-00x.

• UPC 00840682103800
• UPC 00840682145794
• UPC 00840682145558
• UPC 00195278379610

Check against the official notice below — it lists the full affected range.

What happened

GE Healthcare is recalling three versions of its medical imaging software: GE Centricity Universal Viewer 6.0 (Model 2088026-9XX), GE Centricity Universal Viewer 7.0 (Model 5826659-0XX), and GE Universal Viewer 8.0 (Model 5865740-00x). The recall affects approximately 1,690 devices distributed across 40 U.S. states and multiple foreign countries due to inaccurate distance and area measurements when using the Global Stack viewport feature.

The affected software includes specific versions of each model, identified by their UDI codes and software version numbers. The record does not specify a remedy for consumers who have these devices.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Inaccurate Distance and Area measurements with use of Global Stack viewport.

Details from the source

Reason for recall: Inaccurate Distance and Area measurements with use of Global Stack viewport. Distribution: Distribution was made to AR, AZ, CA, CO, DE, FL, GA, IA, ID, IL, IN, KS, LA, MA, MD, ME, MI, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, VT, WA, WI, and WV. There was government distribution and no military distribution. Foreign distribution was made to Argentina, Aruba, Australia, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Domini Quantity: 1,690 devices Lot/code info: (1) Centricity Universal Viewer 6.0 - UDI 00840682103800; Software versions 6.0 SP9, 6.0 SP9.0.1 through 6.0 SP9.0.1.11, 6.0 SP9.0.2, and 6.0 SP10 through 6.0 SP10.4. (2) Centricity Universal Viewer 7.0 - UDI 00840682145794, 00840682145558; Software versions 7.0 through 7.0 SP0.0.4.9, 7.0 SP0.0.5, 7.0 SP0.1.0, and 7.0 SP1. (3) Universal Viewer 8.0 - UDI 00195278379610; Software versions 8.0, 8.0 SP0.1.0, and 8.0 SP0.1.1.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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